BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 32MM ID

    MDR report key: 3324879 · Received September 4, 2013

    Report

    Report Number
    0002249697-2013-02946
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    January 1, 2011
    Report Date
    August 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA CLUSTER 56MM; CAT# 42-11-56F; LOT# MJKP7E, ACCOLADE 132 SIZE 4.5; CAT# 6020-4535; LOT# 33373604, TRIDENT 0° X3 INSERT 36MM ID; CAT# 623-00-36F; LOT# MJKD37, UNKNOWN FEMORAL HEAD 36MM+2.5; CAT# UNK; LOT# 254063. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. DEVICES WERE RETAINED AT DREXEL IMPLANT RESEARCH CENTER. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTER¿S INSTITUTION AND (B)(4) REGULATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER RELEVANT EVENTS FOR THE REPORTED LOT OR STERILE LOT IDS. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~0.5 Y. THE ACETABULAR LINER, ACETABULAR SHELL, FEMORAL HEAD AND FEMORAL STEM COMPONENTS WERE REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROXIMATELY 0.5 Y. THE ACETABULAR LINER, ACETABULAR SHELL, FEMORAL HEAD AND FEMORAL STEM COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438127 TRIDENT 0° X3 INSERT 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MET3TT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention